NCT05873439已完成1 期
A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Rate of Unacceptable Toxicity
研究概览
简要总结
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
- •Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
- •Life expectancy >12 weeks
- •Normal renal (creatinine <1.5 × upper limit of normal [ULN]), liver (bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8)
- •Age ≥ 18 years
- •Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- •There is no limit on prior systemic or therapies
- •Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- •Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur.
排除标准
- •Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
- •Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
- •Women who are pregnant or breastfeeding
- •History of allergy or hypersensitivity to any of the study drugs or study drug components
- •Concurrent brain metastases or leptomeningeal disease
- •History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- •• Patients with vitiligo or alopecia
- •• Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- •• Any chronic skin condition that does not require systemic therapy
- •• Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator
- •• Patients with celiac disease controlled by diet alone
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- •• Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
- •• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- •• Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
研究组 & 干预措施
Arm A: RSI predicts dose ≤ 60 Gy
Experimental
Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.
干预措施: Genomically Guided Radiation Therapy (RT) (Radiation)
Arm B: RSI predicts dose > 60 Gy
Experimental
Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction).
干预措施: Genomically Guided Radiation Therapy (RT) (Radiation)
Arm C: unable to calculate RSI
Experimental
Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.
干预措施: Genomically Guided Radiation Therapy (RT) (Radiation)
结局指标
主要结局
Rate of Unacceptable Toxicity
时间窗: 12 weeks after start of treatment
Rate of Unacceptable Toxicity will be measured during 12 week period following study enrollment. Unacceptable toxicity is defined as any grade 4 or 5 adverse event (AE) probably or definitely related to experimental dose escalated radiation therapy
次要结局
- Freedom from local regional progression (FFLRP)(At 2 years)
- Overall Survival (OS)(At 2 years)
研究者
研究点 (1)
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